Data / Medical devices / United States / Implant Solutions Pty Ltd (trading AS Osteon Medical)
Implant Solutions Pty Ltd (trading AS Osteon Medical): FDA-registered device maker in Irvine, CA, United States, 3 510(k) clearances
Implant Solutions Pty Ltd (trading AS Osteon Medical) is registered with the FDA (registration 3023878501) in Irvine, CA, United States. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 9, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3023878501
- Address
- Suite 150, 175 Technology Drive, Irvine, CA, United States, 92618
- Owner or operator
- Osteon Medical (10081414)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- July 5, 2022
- Registered through
- 2026
- Brand names listed
- Osteon Precision Milled Suprastructure, Osteon Prosthesis
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Dentures, Full | NSL | N | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dentures, Partial | NSK | N | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Restoration, Base Metal | NSQ | N | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Restoration, Porcelain | NSP | N | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Restoration, Resin | NSM | N | Manufacturer | accessdata.fda.gov |
| Restoration, Resin, Crown And Bridge | NSN | N | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 9, 2024 | K233083 | Osteon Precision Milled Suprastructure | NHA | Substantially Equivalent | Implant Solutions Pty Ltd (Aka Osteon Medical) | accessdata.fda.gov |
| July 5, 2022 | K221019 | Osteon Precision Milled Suprastructure | NHA | Substantially Equivalent | Implant Solutions Pty Ltd (Aka Osteon Medical) | accessdata.fda.gov |
| March 3, 2022 | K212676 | Osteon Precision Milled Suprastructure | NHA | Substantially Equivalent | Implant Solutions Pty Ltd (Osteon Medical) | accessdata.fda.gov |
Compare with other makers
- All makers of Restoration, Base Metal
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Dentures, Full
- All makers of Restoration, Resin
- All makers of Restoration, Resin, Crown And Bridge
- All makers of Restoration, Porcelain
Updated March 9, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.